Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EIS · Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
103 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992649 | ATD AUTOMATIC BRIDGE REMOVER | J. Morita USA, Inc. | 1999-10-29 | 84 | 0 |
| K951299 | EASY PNEUMATIC CROWN AND BRIDGE REMOVER | Dentco, Inc. | 1995-08-29 | 160 | 0 |
| K863500 | STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR | Pacific Union Dental, Inc. | 1986-09-22 | 13 | 0 |
| K854795 | HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER | Fran Hazelton Co. | 1986-03-04 | 92 | 0 |
| K842026 | H-TYPE BRIDGE REMOVER | Higa Manufacturing , Ltd. | 1984-07-11 | 54 | 0 |
| K833287 | SATIN CAST ECONOCAST | Genesis Industries, Inc. | 1984-01-03 | 103 | 0 |
| K833290 | C & B 40 PENTRO C & B40 | Genesis Industries, Inc. | 1984-01-03 | 103 | 0 |
| K833278 | C & B 45 | Genesis Industries, Inc. | 1983-12-29 | 98 | 0 |
| K833289 | C & B 61 PENTRON C & B61 | Genesis Industries, Inc. | 1983-12-29 | 98 | 0 |
| K833736 | GOLD-PALLADIUM-SILVER BASED CAST/ALLOY | Jeneric Ind. | 1983-12-29 | 65 | 0 |
| K833280 | SUPRA AP CHOICE 83 | Genesis Industries, Inc. | 1983-12-26 | 95 | 0 |
| K833285 | RX IV PENTRON IV | Genesis Industries, Inc. | 1983-12-22 | 91 | 0 |
| K833288 | C & B57 PENTRON C & B57 | Genesis Industries, Inc. | 1983-12-20 | 89 | 0 |
| K833279 | NATURELLE-LITE | Genesis Industries, Inc. | 1983-11-28 | 67 | 0 |
| K833281 | RX D PENTRON | Genesis Industries, Inc. | 1983-11-28 | 67 | 0 |
| K833282 | RX NYSP PENTRON 60 | Genesis Industries, Inc. | 1983-11-28 | 67 | 0 |
| K833283 | RX ORY PENTRON C & B | Genesis Industries, Inc. | 1983-11-28 | 67 | 0 |
| K833284 | RX 41 PENTRON 41 | Genesis Industries, Inc. | 1983-11-28 | 67 | 0 |
| K833286 | RX SEG ECONOPLUS | Genesis Industries, Inc. | 1983-11-28 | 67 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda